Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

Not Applicable

Completed

• Conditions: Interstitial Lung Disease
• Interventions: Other: NMES Group; Other: Control Group

• Registration Number: NCT02497144
• Lead Sponsor: Gazi University

Brief Summary

Decreased exercise capacity and quality of life, increased dyspnea and fatigue perception and hypoxemia during exercise is seen in patients with interstitial lung disease. Impaired ventilatory response, increased lung compliance, ventilation-perfusion mismatching and inadequate peripheral circulation causes decreased exercise capacity. Another important factor that induce decreased exercise capacity is peripheral muscle weakness. In literature, there is no study investigated effects of neuromuscular electrical stimulation on functional exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical activity level, dyspnea and fatigue perception in patients with interstitial lung disease.

Detailed Description

In literature, there was increased quantity of study investigated effects of neuromuscular electrical stimulation in chronic lung disease patients. It was used as a pulmonary rehabilitation component especially in patients with decreased exercise capacity and peripheral muscle strength, intensely increased dyspnea inhibits exercise. It was demonstrated that neuromuscular electrical stimulation improved functional exercise capacity, peripheral muscle strength and quality of life.

Study Timeline

• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Study Start: 2015-07-15
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosed with interstitial lung disease
• Clinically stable
• Under standard medication
• Having no exacerbation or infection

Exclusion Criteria

• Cognitive disorders
• Orthopedic and neurological problems
• Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES Group	NMES Group	Intervention: NMES group will receive neuromuscular electrical stimulation using high frequency galvanic stimulation and breathing exercises. Neuromuscular electrical stimulation will be applied bilaterally to quadriceps femoris muscle for 3days/6 weeks by a physiotherapist. NMES group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.
Control Group	Control Group	Sham: Control group will receive breathing exercises. Control group will perform breathing exercises 120 times/day, 7 days/week, for 6 weeks. Control group will be followed-up by telephone once a week.

Primary Outcome Measures

Name	Time	Method
Functional exercise capacity	6 weeks	Six minute walk test

Secondary Outcome Measures

Name	Time	Method
Pulmonary functions	6 weeks	Spirometry
Maximal exercise capacity	6 weeks	Incremental shuttle walk test
Depression	6 weeks	Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
Generic quality of life	6 weeks	Short Form (SF-36) Health Survey
Disease specific quality of life	6 weeks	Saint George Quality of Life Questionnaire
Inspiratory and expiratory muscle strength (MIP,MEP)	6 weeks	Mouth pressure device
Dyspnea	6 weeks	Modified Borg and Modified Medical Research Council (MMRC) Dyspnea scales
Peripheral muscle strength	6 weeks	Hand held dynamometer
Fatigue	6 weeks	Fatigue Severity Scale
Physical activity	6 weeks	Metabolic holter
Cough related quality of life	6 weeks	Leicester Cough Questionnaire

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey